An interventional study of Auricular Indwelling Needles and Sham Auricular Indwelling Needles in Internal Haemorrhoids, sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by University of Medicine and Pharmacy at Ho Chi Minh City · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if adding small ear needles to a standard oral medicine can ease symptoms in adults with early-stage internal hemorrhoids (swollen blood vessels inside the anus, grade I-II) who also have the "heat-toxin syndrome" of traditional medicine. In this pattern, people typically have bright red bleeding when passing stool, a burning feeling in the anus, dry stool, dark yellow urine, a dry throat with a bitter taste, a red tongue with a greasy yellow coating, and a rapid pulse. The trial will also learn about the safety of the ear needles.
The main questions it aims to answer are:
Does adding ear needles to the standard medicine lower anal discomfort or pain during bowel movements after 14 days? Does it also reduce bleeding and prolapse (hemorrhoids that come out of the anus) and improve quality of life? What side effects do participants have with the ear needles and with the medicine?
Researchers will compare two groups to see if the ear needles help beyond the standard medicine alone. One group will receive ear needles and the other will receive look-alike ear patches with the needle removed (a "sham" treatment, used so that participants cannot tell which treatment they received). Both groups will take the same medicine, diosmin/hesperidin (Daflon 500 mg), and receive the same diet and lifestyle advice.
Participants will:
Take Daflon 500 mg tablets for 14 days Have ear needles or sham patches placed on seven points of one ear on Day 0 and Day 7 (switching ears each time), and have them removed on Day 5 and Day 12 Press the needles or patches gently at least 3 times a day for 1 minute each time Visit the clinic on Day 0, Day 7 and Day 14 to report their pain (on a 0-10 scale), bleeding and prolapse, and to complete a quality-of-life questionnaire (Day 0 and Day 14) Report any side effects to the study team
Rationale. MPFF improves venous tone and is a standard conservative treatment, yet residual anal discomfort or pain is common and affects quality of life. Auricular points related to the anorectal region may relieve pain and bleeding through neuromodulation. In traditional medicine, a large share of patients with internal hemorrhoids present with the heat-toxin syndrome. Auricular indwelling needles provide continuous stimulation with low invasiveness, but controlled evidence in this population is limited.
Objectives. To compare auricular indwelling needles plus MPFF with sham patches plus MPFF in adults with Goligher grade I-II internal hemorrhoids and the heat-toxin syndrome, regarding (1) anal discomfort/pain during defecation (VAS) at Day 7 and Day 14; (2) bright red bleeding and prolapse at Day 7 and Day 14; (3) quality of life (EQ-5D-5L) at Day 14; (4) adverse events during 14 days.
Design and setting. Randomized, participant-blinded, sham-controlled, two-arm parallel trial at the outpatient clinics of Le Van Thinh Hospital, Ho Chi Minh City, Vietnam. A surgeon confirms internal hemorrhoids of Goligher grade I-II. A traditional medicine physician confirms the heat-toxin syndrome using the criteria in the eligibility section, adapted from the Vietnam Ministry of Health guideline (2020) and the Chinese hemorrhoid guideline of the Chinese Association of Integrative Medicine (2020). Participants give written informed consent.
Randomization and blinding. The allocation sequence (1:1, simple randomization) was generated before enrollment with the RAND function of Microsoft Excel. Group codes are kept in sequentially numbered, sealed, opaque envelopes, opened by the treating physician only after eligibility is confirmed and consent is signed. Participants are told only their group letter (A or B) and are not told how the groups differ. The treating physician cannot be blinded.
Interventions. Both groups: MPFF (Daflon 500 mg; diosmin 450 mg and hesperidin 50 mg per tablet) for 14 days (3 tablets twice daily for 4 days, 2 tablets twice daily for 3 days, then 1 tablet twice daily for 7 days), plus advice on a high-fiber diet, adequate fluids, avoiding spicy food, alcohol and tobacco, and avoiding prolonged sitting or standing. Experimental group: Khanh Phong auricular indwelling needles (0.22 x 1.3 mm) at seven points: Anus (HX5), Rectum (HX2), Sympathetic (AH6a), Shenmen (TF4), Lung (CO14), Large Intestine (CO7) and Sanjiao (CO17), one ear per session, alternating ears (right ear first). Session 1 runs from Day 0 to Day 5 and session 2 from Day 7 to Day 12, with a 2-day ear-free interval. Participants press the needles at least 3 times daily for 1 minute. Sham group: identical patches with the needle removed, applied at the same points, on the same schedule and with the same instructions.
Assessments. VAS, bleeding grade and prolapse grade at Day 0, Day 7 and Day 14; EQ-5D-5L at Day 0 and Day 14; adverse events throughout the 14 days.
Sample size. Calculated for a two-group comparison of means for the VAS change (two-sided alpha 0.05, power 80%), assuming a between-group difference of 1.73 points (Cohen's d = 0.75) and SD 2.31, giving 28 participants per group. A 10% allowance gives 32 per group (64 in total).
Statistical analysis. Stata 17. Continuous variables: mean (SD) or median (IQR). Categorical variables: n (%). Between-group comparisons: t-test or Mann-Whitney U test for continuous and ordinal data, chi-square or Fisher's exact test for categorical data. Within-group changes: paired t-test or Wilcoxon signed-rank test.
Safety and discontinuation. Needle fainting, local inflammation, intolerable pain and bleeding at the needle site are managed according to the Vietnam Ministry of Health acupuncture procedures. Participants who develop heavy rectal bleeding or other emergency signs have the needles removed and are referred to the hospital's surgical or emergency department; serious events are reported to the ethics committee within 24 hours. Participants are withdrawn if they decide to stop, develop serious allergy or complications, or start other hemorrhoid treatments.
238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.
This study's planned enrollment of 64 is below the median of 100 across 183 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →University of Medicine and Pharmacy at Ho Chi Minh City is the lead sponsor of 127 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Presence of both of the following clinical symptom thresholds at baseline:
Confirmed diagnosis of Traditional Medicine Heat-Toxicity Syndrome (Hoi chung Nhiet doc, per the 2020 Vietnam Ministry of Health Guidelines and the 2020 Chinese Association of Integrative Medicine Guidelines for Hemorrhoids), requiring fulfillment of all three of the following conditions:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive standard conservative therapy including dietary/lifestyle counseling and oral Micronized Purified Flavonoid Fraction (Daflon 500 mg: Diosmin 450 mg + Hesperidin 50 mg) for 14 days (3 tablets twice daily for Days 1-4, 2 tablets twice daily for Days 5-7, and 1 tablet twice daily for Days 8-14), combined with Real Auricular Indwelling Needles (0.22 x 1.3 mm) inserted at 7 unilateral auricular acupoints: Anus (HX5), Rectum (HX2), Sympathetic (AH6a), Shenmen (TF4), Lung (CO14), Large Intestine (CO7), and Triple Energizer (CO17). Needles are applied in 2 cycles: Cycle 1 on the right ear from Day 0 to Day 5 (retained for 5 days, followed by a 2-day rest period), and Cycle 2 on the left ear from Day 7 to Day 12 (retained for 5 days). Participants manually press the needles at least 3 times daily for 1 minute each time.
Device: Auricular Indwelling Needles · Drug: Micronized Purified Flavonoid Fraction (Diosmin and Hesperidin)
Participants receive the exact same standard conservative therapy including dietary/lifestyle counseling and oral Micronized Purified Flavonoid Fraction (Daflon 500 mg: Diosmin 450 mg + Hesperidin 50 mg) for 14 days (3 tablets twice daily for Days 1-4, 2 tablets twice daily for Days 5-7, and 1 tablet twice daily for Days 8-14), combined with Sham Auricular Indwelling Needles (identical Khanh Phong adhesive patches with the microneedle tip completely removed to prevent skin penetration) applied at the exact same 7 unilateral auricular acupoints: Anus (HX5), Rectum (HX2), Sympathetic (AH6a), Shenmen (TF4), Lung (CO14), Large Intestine (CO7), and Triple Energizer (CO17) following the same 2-cycle schedule (Right ear Days 0-5; Left ear Days 7-12) and manual pressing instructions (at least 3 times daily for 1 minute each time).
Device: Sham Auricular Indwelling Needles · Drug: Micronized Purified Flavonoid Fraction (Diosmin and Hesperidin)
Sterile, single-use intradermal auricular press needles (Khanh Phong / Tianxie brand, dimensions 0.22 x 1.3 mm, approved by the Vietnam Ministry of Health under Decision No. 287/BYT-YDCT) are inserted perpendicularly to a depth of 1.3 mm after 70% isopropyl alcohol disinfection at 7 auricular acupoints: Anus (HX5), Rectum (HX2), Sympathetic (AH6a), Shenmen (TF4), Lung (CO14), Large Intestine (CO7), and Triple Energizer (CO17). Treatment consists of 2 cycles over 14 days: Cycle 1 on the right ear (inserted on Day 0, removed on Day 5, followed by a 2-day rest period) and Cycle 2 on the left ear (inserted on Day 7, removed on Day 12). Participants press the plastered acupoints at least 3 times per day for 1 minute per session to elicit mild soreness, warmth, or distension (Deqi sensation).
Also known as: Khanh Phong Press Needles, Auricular Press Needles, Tianxie Disposable Press Needles (0.22 x 1.3 mm), Auricular Acupuncture
Identical adhesive patches (Khanh Phong / Tianxie brand) from which the stainless-steel microneedle tip has been completely removed so that no skin penetration or mechanical needle stimulation occurs. Following 70% isopropyl alcohol disinfection, the sham patches are adhered to the exact same 7 unilateral auricular acupoints-Anus (HX5), Rectum (HX2), Sympathetic (AH6a), Shenmen (TF4), Lung (CO14), Large Intestine (CO7), and Triple Energizer (CO17)-on the right ear for Cycle 1 (Day 0 to Day 5) and the left ear for Cycle 2 (Day 7 to Day 12). Participants are instructed to press the patches at least 3 times per day for 1 minute per session, identical to the active intervention group.
Also known as: on-penetrating Sham Auricular Patches, Placebo Press Needles, Placebo Indwelling Needles
Oral film-coated tablets containing 500 mg of Micronized Purified Flavonoid Fraction (450 mg micronized Diosmin and 50 mg Hesperidin; Daflon 500 mg, manufactured by Servier, France; Vietnam Drug Administration registration No. 3109/QLD-DK). Administered orally for 14 days per the Vietnam Ministry of Health acute hemorrhoidal regimen (Decision No. 5013/QD-BYT): 3 tablets twice daily (3,000 mg/day) for the first 4 days (Days 1 - 4), followed by 2 tablets twice daily (2,000 mg/day) for the next 3 days (Days 5 - 7), and 1 tablet twice daily (1,000 mg/day) for the subsequent 7 days (Days 8 - 14). All participants also receive standardized dietary and lifestyle counseling (high-fiber diet, 1.5 - 2 L water/day, avoidance of spicy food/alcohol/prolonged sitting or straining).
Also known as: Daflon 500 mg, MPFF (Diosmin 450 mg / Hesperidin 50 mg)
Change in Anal Pain or Discomfort During Defecation Assessed by Visual Analogue Scale (VAS)
Self-reported intensity of anal pain or discomfort experienced during defecation, measured using a continuous 100-mm (10-cm) horizontal Visual Analogue Scale (VAS) ranging from 0 ('no anal discomfort or pain') to 10 ('worst imaginable pain'). Higher scores indicate more severe anal pain or discomfort.
Time frame: Baseline (Day 0), Day 7, and Day 14
Proportion of Bowel Movements With Bright Red Rectal Bleeding
Calculated for each assessment period as the number of bowel movements accompanied by bright red rectal bleeding divided by the total number of bowel movements recorded in the participant's daily defecation diary, expressed as a ratio/percentage ranging from 0% to 100%. Higher values indicate a higher frequency of defecation-related bleeding.
Time frame: Baseline (Day 0), Day 7 (covering Week 1), and Day 14 (covering Week 2)
Severity Grade of Bright Red Rectal Bleeding During Defecation
Assessed using a 4-point ordinal symptom severity scale: Grade 0 (None: no bleeding), Grade 1 (Mild: blood streaks on toilet paper or detected only upon touching the anus), Grade 2 (Moderate: dripping blood clearly visible in the toilet bowl or coating the stool, associated with straining), and Grade 3 (Severe: jet-like or squirting bleeding filling the toilet bowl). Higher grades indicate worse bleeding severity.
Time frame: Baseline (Day 0), Day 7, and Day 14
Severity Grade of Internal Hemorrhoidal Prolapse During Defecation (Goligher Classification)
Assessed using the 4-grade ordinal Goligher classification scale during defecation or straining: Grade I (No prolapse outside the anal canal), Grade II (Hemorrhoidal cushions prolapse during defecation or straining but reduce spontaneously), Grade III (Hemorrhoidal cushions prolapse during defecation or straining and require manual reduction), and Grade IV (Permanently prolapsed and irreducible). Higher grades indicate more severe hemorrhoidal prolapse.
Time frame: Baseline (Day 0), Day 7, and Day 14
Change in Health-Related Quality of Life Assessed by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Utility Score
Health-related quality of life assessed across 5 dimensions-Mobility (MO), Self-Care (SC), Usual Activities (UA), Pain/Discomfort (PD), and Anxiety/Depression (AD)-each rated on 5 severity levels (Level 1 = no problems to Level 5 = extreme problems/unable to perform). The resulting 5-digit health state profile is converted into a single summary index utility score using the validated Vietnam EQ-5D-5L value set (Mai et al., 2020), where 1.0000 represents full health (11111) and lower scores indicate worse health-related quality of life.
Time frame: Baseline (Day 0) and Day 14
Incidence of Treatment-Emergent Adverse Events Related to Auricular Press Needles and Oral Diosmin/Hesperidin
Number and percentage of participants experiencing any treatment-emergent adverse events (TEAEs) recorded via clinical observation and patient self-report, categorized into: (1) Auricular press needle-related events: acupuncture syncope/vasovagal reaction (dizziness, hypotension, diaphoresis), intolerable local ear pain requiring needle removal, local auricular inflammation or infection (redness, swelling, heat, pain, or cellulitis), and local bleeding at the acupoint upon needle removal; and (2) Oral Daflon-related events: gastrointestinal symptoms (dyspepsia, epigastric pain, nausea, vomiting) and non-gastrointestinal events (urticaria, rash).
Time frame: From Baseline (Day 0) through Day 14
No study locations are listed for this record.
Plan to share: Yes
Supporting information: Study protocol
Start is estimated for Nov 2026; primary completion for May 2027, 5 months later.
Of 65 non-industry interventional studies with no phase under Hemorrhoids, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 35. This study's planned 5 months is below that.
Counting every sponsor, half of 70 studies reached it within 23 months; a quarter within 10 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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